REGRANEX Rx

Therapeutic Use:

Indications for REGRANEX:

Adjunct in the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply.

Adult:

≥16yrs: Apply once daily until complete healing has occurred. Measure size of ulcer and adjust at 1–2 week intervals. Calculate amount of gel needed based on ulcer size and product tube size. Squeeze calculated length of gel from tube onto clean measuring surface (eg, wax paper). Spread gel over entire ulcer to thickness of about 1/16 inch. Cover with saline dressing for about 12 hrs. Remove dressing and rinse. Replace with clean saline dressing (no gel). Reevaluate if ulcer does not decrease in size by about 30% after 10 weeks, or if complete healing has not occurred after 20 weeks. To calculate amount of gel in centimeters: If using the 15g tube: Length of gel (in cm) to be applied daily = wound area (length x width in cm2) ÷ 4. If using the 2g tube: Length of gel (in cm) to be applied daily = wound area (length x width in cm2) ÷ 2.

Children:

<16yrs: not recommended.

Contraindications:

Neoplasm(s) at application site.

Boxed Warning:

Increased rate of mortality secondary to malignancy.

Warnings/Precautions:

Systemic malignancies (increased death rate with ≥3 tubes of becaplermin gel treatment). Not for use in wounds that close by primary intention. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Growth factor.

Adverse Reactions:

Erythematous rash.

How Supplied:

Gel—2g, 15g

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